Cardiome Pharma announced that it has received an approvable letter from the US Food and Drug Administration (FDA) for oxypurinol for allopurinol-intolerant hyperuricemia (gout). The letter states that prior to final marketing approval, the FDA requires additional clinical and manufacturing data from Cardiome, a statement from the company said.

The approvable letter follows Cardiome's submission of an NDA package in December of 2003 under sub-part H of the Food and Drug Act. This use of oxypurinol has been declared an orphan indication in the US.

"While we are pleased that the FDA agrees that oxypurinol is approvable, we are disappointed with their apparent decision which will at least delay patients gaining commercial access to oxypurinol," said Bob Rieder, president & CEO of Cardiome. "The gout market opportunity is very small and Cardiome is strongly focused on its attractive cardiovascular drug development programmes. We will reflect on the FDA comments and meet with the FDA prior to making any final decisions on the future of this NDA or the compassionate-use programme," he added.

Gout is a chronic and potentially debilitating disease characterized by painful arthritis attacks that afflicts more than two million patients in the US.